Hand-held ultrasound system having sterile enclosure

ABSTRACT

A sterile enclosure is provided for enclosing a hand-held ultrasound device to prevent any material on the ultrasound device from contaminating a sterile environment in which the ultrasound device is used. The enclosure has an opening for insertion of the ultrasound device into the enclosure, a closure for closing the opening, an acoustically-transparent transducer portion for covering an active face of a transducer of the ultrasound device, and a transparent display portion overlaying a display of the ultrasound device. In some embodiments a detachable or integrally formed needle guide is provided with the enclosure, for holding and guiding a needle so that the needle is projected into a field of view of the transducer of the ultrasound device.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority from U.S. patent application No.60/955,327 filed 10 Aug. 2007 and entitled HAND-HELD ULTRASOUND SYSTEMHAVING STERILE ENCLOSURE. This application claims the benefit under 35U.S.C. §119 of U.S. patent application No. 60/955,327 filed 10 Aug. 2007and entitled HAND-HELD ULTRASOUND SYSTEM HAVING STERILE ENCLOSURE whichis hereby incorporated herein by reference.

TECHNICAL FIELD

This invention relates to a hand-held apparatus for obtaining ultrasoundimages. Particular embodiments of the invention relate to enclosures forhand-held ultrasound imaging devices.

BRIEF DESCRIPTION OF DRAWINGS

A number of example embodiments are illustrated in the attacheddrawings. These example embodiments are illustrative and are notintended to be restrictive.

FIG. 1 shows a hand-held ultrasound apparatus.

FIG. 2 shows a hand-held ultrasound apparatus like that of FIG. 1 in asterile enclosure.

FIG. 3 is a cross section through a hand-held ultrasound apparatus in asterile enclosure that has a bag-like configuration and is stretchedover a transducer of the ultrasound apparatus.

FIG. 4 is a cross section through a hand-held ultrasound apparatus in asterile enclosure of an elastic material that is stretched over atransducer of the ultrasound apparatus.

FIG. 5 is a cross section through a hand-held ultrasound apparatus in asterile enclosure comprising a semi-rigid gel pad that is formed toconform to a transducer of the ultrasound apparatus.

FIG. 6 is a cross section through a portion of a sterile enclosurehaving a pre-dispensed gel covered by a removable protective layer in aportion to be positioned adjacent a transducer.

FIG. 7 shows a sterile enclosure equipped with an integrated needleguide.

FIG. 8 shows a sterile enclosure equipped with a removable needle guide.

DESCRIPTION

Throughout the following description specific details are set forth inorder to provide a more thorough understanding to persons skilled in theart. However, well known elements may not have been shown or describedin detail to avoid unnecessarily obscuring the disclosure. Accordingly,the description and drawings are to be regarded in an illustrative,rather than a restrictive, sense.

This invention has a number of aspects that may be implementedseparately or in [[an]] suitable combinations. The features as describedherein may be combined in any suitable combinations with the featuresdescribed in the commonly-owned US provisional patent applicationsentitled:

-   -   HAND-HELD ULTRASOUND IMAGING DEVICE HAVING RECONFIGURABLE USER        INTERFACE (application No. 60/955,328);    -   POWER MANAGEMENT IN PORTABLE ULTRASOUND DEVICES (application No.        60/955,329);    -   HAND-HELD ULTRASOUND IMAGING DEVICE HAVING REMOVABLE TRANSDUCER        ARRAYS (application No. 60/955,325);    -   WIRELESS NETWORK HAVING PORTABLE ULTRASOUND DEVICES (application        No. 60/955,331); and,    -   HANDHELD ULTRASOUND IMAGING SYSTEMS (application No. 60/977,353)        all of which are hereby incorporated herein by reference. The        features as described herein may also be combined in any        suitable combinations with the features described in the        commonly-owned US non-provisional patent applications which are        filed on the same day as the instant application and entitled:    -   HAND-HELD ULTRASOUND IMAGING DEVICE HAVING RECONFIGURABLE USER        INTERFACE (claiming priority from application No. 60/955,328);    -   POWER MANAGEMENT IN PORTABLE ULTRASOUND DEVICES (claiming        priority from application No. 60/955,329);    -   HAND-HELD ULTRASOUND IMAGING DEVICE HAVING REMOVABLE TRANSDUCER        ARRAYS (claiming priority from application No. 60/955,325);    -   WIRELESS NETWORK HAVING PORTABLE ULTRASOUND DEVICES (claiming        priority from application No. 60/955,331); and    -   HANDHELD ULTRASOUND IMAGING SYSTEMS (claiming priority from        application No. 60/977,353); all of which are hereby        incorporated herein by reference.

One aspect of the invention provides a hand-held ultrasound apparatushaving a removable sterile enclosure. The hand-held ultrasound apparatusmay comprise a transducer, processing circuitry and a display to displayultrasound images. The hand-held ultrasound apparatus may be powered bybatteries or the like. FIG. 1 shows an example hand-held ultrasoundapparatus 10. Apparatus 10 comprises a display 14 on which can bedisplayed an ultrasound image 15. Apparatus 10 also comprises atransducer array 20.

FIG. 2 shows hand-held ultrasound apparatus 10 enclosed in a sterileenclosure 30. Sterile enclosure 30 has an opening 32 through whichultrasound apparatus 10 can be introduced into sterile enclosure 30.Sterile enclosure 30 has a closure 34 which closes opening 32 afterultrasound apparatus 10 is inside enclosure 30. A number of individualfeatures of sterile enclosures according to specific embodiments aredescribed below. These features may be combined in various ways,including but not limited to those described below.

Sterile enclosures may comprise any suitable closure capable of closingthe opening through which the hand-held ultrasound apparatus is insertedwithin the sterile enclosure. For example, the closure may comprise aflap which can be sealed over the opening to close the opening by way ofa suitable adhesive, or a pair of adhesive flaps that may be sealedtogether to cover the opening. The closure may comprise a suitable zipfastener, hook and loop fastener, magnetic closure, or the like.

The sterile enclosure allows the hand-held ultrasound apparatus to beused in an environment in which sterility is to be maintained, such asan operating theater. The sterile enclosure can be changed to preventtransmission of disease from one subject to another in sterile ornon-sterile surroundings. For example, the sterile enclosure may bedisposed of after use and replaced with another sterile enclosure,thereby permitting the hand-held ultrasound apparatus to be used onpeople or animals having potentially contagious conditions withoutrisking the transfer of disease from one person or animal to another.

The sterile enclosure includes a portion that isacoustically-transparent (i.e. substantially transparent to ultrasonicvibrations) such that the transducer can transmit ultrasonic pulseswhich pass through the sterile enclosure into a subject, and can receiveultrasonic pulses which are reflected at locations within the subjectand pass back through the sterile enclosure to the transducer. At leastthose portions of the sterile enclosure which overlie the display areoptically transparent such that an operator can view the display of thehand-held ultrasound apparatus while it is kept within the sterileenclosure.

The hand-held ultrasound apparatus may have various controls foradjusting its settings, turning it on or off, and the like. Thesecontrols may be actuated through the sterile enclosure either byproviding touch-sensitive controls which can be operated by an operatorthrough the sterile enclosure or controls which can sense the presenceof an operator's finger through the sterile enclosure. Such controls mayuse any suitable modality to detect the presence of the operator'sfinger. In embodiments where the controls are pressure sensitive, atleast the portions of the sterile enclosure overlying the controls areflexible so that forces exerted by an operator's fingers are transmittedthrough the sterile enclosure to actuate the controls.

A hand-held ultrasound apparatus according to the invention may also orin the alternative be made responsive to voice or other sound commandswhich can be transmitted to the hand-held ultrasound apparatus throughthe sterile enclosure. In such embodiments, the hand-held ultrasoundapparatus comprises a microphone and a voice-recognition apparatus (thatmay comprise a suitably-programmed data processor for example).

The sterile enclosure may completely enclose the hand-held ultrasoundapparatus and therefore positively prevent any material on the hand-heldultrasound apparatus from contaminating a sterile environment in whichthe hand-held ultrasound apparatus is used while in the sterileenclosure.

The sterile enclosure may have a variety of forms. In some embodiments,the sterile enclosure is bag-like and has an opening through which theultrasound apparatus can be inserted into the interior of the sterileenclosure. A closure is provided to close the opening. Means may beprovided to tighten the bag-like sterile enclosure around the transducerso that there are no air bubbles or the like between the transducer andthe sterile enclosure.

FIG. 3 is a cross section through an ultrasound apparatus 10 enclosed ina bag-like enclosure 30A. An elastic band 36 encircles ultrasoundapparatus 10 and holds a portion 37 of enclosure 30A stretched over anactive face 20A of transducer array 20.

In other embodiments, the sterile enclosure comprises an elasticmaterial that is a stretch fit over the hand-held ultrasound apparatus,or portions thereof. For example, the transparent material may comprisea transparent latex or similar material. The elastic material maystretch over the transducer and/or the display of the hand-heldultrasound apparatus.

FIG. 4 is a cross section through an ultrasound apparatus 10 enclosed inan enclosure 30B comprising an elastic material. The elastic material ofenclosure 30B is stretched over an active face 20A of transducer array20.

In other embodiments the sterile enclosure has a shape that conforms toprojections or other features of configuration of the hand-heldultrasound apparatus. When these projections are received incorresponding portions of the sterile enclosure they prevent the sterileenclosure from shifting relative to the ultrasound apparatus as theultrasound apparatus is used.

The portion of the sterile enclosure that is adjacent to the ultrasoundtransducer on the hand-held ultrasound apparatus may be configured in anumber of different ways. In some embodiments, the enclosure comprisesan acoustically-transparent material that holds its shape (i.e. issemi-rigid) and has a shape that conforms to the shape of thetransducer. For example, the semi-rigid material may comprise a gelmaterial. The material may be the same material used for the gel pads,sometimes called “aqueous standoffs”, that are used in ultrasonography.

In some embodiments a gel pad is built into the sterile enclosure andshaped to conform to a shape of at least an active face of thetransducer. An outer surface of the gel pad (or otheracoustically-transparent material) may be coated with a slipperymaterial at least in the vicinity of the transducer so that it can slideeasily over the skin of a subject.

FIG. 5 is a cross section through a hand-held ultrasound apparatus 10 ina sterile enclosure 30C comprising a semi-rigid gel pad 38 that isformed to conform to the active face 20A of transducer 20 of theultrasound apparatus 10.

The gel pad may comprise projections and/or recesses that can be engagedwith corresponding recesses and/or projections in the ultrasoundapparatus, in order to better retain the gel pad in contact with thetransducer of the ultrasound apparatus.

In other embodiments, the portion of the sterile enclosure through whichultrasound is transmitted and received may comprise a thin layer ofelastic material that is a stretch fit over the transducer. In somecases, a sterile clip may be applied from the outside of the sterileenclosure to hold the material stretched over the active face of thetransducer.

In some embodiments, an acoustic gel may be provided between thetransducer and the inside of the sterile enclosure. The sterileenclosure may be provided with the acoustic gel already in place. Theacoustic gel may be covered by a removable strip or the like.

FIG. 6 is a cross section through a portion of a sterile enclosure 30having a pre-dispensed acoustic gel 40 covered by a removable protectivelayer 41 in a portion of enclosure 30 to be positioned adjacent atransducer 20. Protective layer 41 may be removed prior to inserting ahand-held ultrasound apparatus 10 into enclosure 30.

In other embodiments means may be provided for delivering acoustic gelto the interface between the transducer and the sterile enclosure. Forexample, the sterile enclosure or the hand-held ultrasound apparatus maycomprise a compartment containing acoustic gel which can be extrudedfrom the compartment into the space between the transducer and theinside of the sterile enclosure either after the hand-held ultrasoundapparatus has been placed into the sterile enclosure or before or duringplacing the hand-held ultrasound apparatus into the sterile enclosure.The acoustic gel may ensure good acoustic contact between the transducerand the inside of the sterile enclosure. Acoustic gel may also be placedon the outside of the sterile enclosure during use to facilitate slidingof the combined ultrasound apparatus and sterile enclosure over the skinof a patient as well as to establish good ultrasonic acoustical couplingbetween the ultrasound apparatus and the subject.

In some cases, a hand-held ultrasound apparatus may be useful forguiding a needle to a specific location in a subject. For example, aneedle may be used for taking biopsy samples of tissues from within asubject or guiding a needle into a vein, artery or other anatomicalstructure in the subject. In such cases, the hand-held ultrasoundapparatus may be used to guide a needle, such as a biopsy needle, to adesired location in a tissue of interest which can be identified in anultrasound image. In such cases, an apparatus according to the inventionmay provide a needle guide built into or attachable to the outside ofthe sterile enclosure or provided in a way that permits the needle guideto be clipped on to the outside of the sterile enclosure. The needleguide may, for example, comprise a holder for a needle which permitsaxial movement of the needle into an acoustical field of view of theultrasound transducer such that the tissues into which the needle may beintroduced by axial movement are imaged on a display of the hand-heldultrasound apparatus. The operator can thereby place the needle toacquire a biopsy sample from a desired position within the tissue withreference to an ultrasound image displayed on the display of thehand-held ultrasound apparatus.

FIG. 7 shows a sterile enclosure 30D equipped with an integrally formedneedle guide 50. Needle guide 50 comprises a bore 52 that is aligned sothat a needle 53 extending through bore 52 projects into a field of view54 of a transducer 20 of an ultrasound apparatus 10 within sterileenclosure 30D. Needle 53 can move axially within bore 52 as indicated byarrow 55. Ultrasound apparatus 10 may be configured to overlay on anultrasound image 15 a line or other indicia 57 indicating the path alongwhich needle 53 can be advanced (which is constrained by needle guide50). An operator can position the ultrasound apparatus 10 so that ananatomical structure of interest seen in image 15 intersects indicia 57.The operator can then advance needle 53 to a desired location to take abiopsy or the like. The operator can monitor the advance of needle 52 inultrasound image 15.

FIG. 8 shows a sterile enclosure 30E similar to sterile enclosure 50D ofFIG. 7 except that needle guide 50 is detachable.

A sterile enclosure may be shipped inside-out to facilitate applying thesterile enclosure over an ultrasound apparatus without rendering whatwill be the exposed outer surface of the sterile enclosure non-sterilethrough contact with the ultrasound apparatus or a person's non-sterileglove or hand.

It can be seen that embodiments of this invention provide:

-   -   sterile enclosures for hand-held ultrasound units;    -   combinations of a hand-held ultrasound unit with a sterile        enclosure enclosing and covering the hand-held ultrasound unit        to permit use of the hand-held ultrasound unit in a sterile        environment; and,    -   methods for using a hand-held ultrasound unit which involve        encasing the hand-held ultrasound unit in a sterile enclosure        prior to use such that a display of the hand-held ultrasound        unit can be viewed through the sterile enclosure, controls of        the hand-held ultrasound unit can be manipulated through the        sterile enclosure, and acoustic signals can be transmitted from        the hand-held ultrasound unit through the sterile enclosure into        a subject and reflections of those transmitted signals can be        passed backed to the hand-held ultrasound unit through the        sterile enclosure.

While a number of exemplary aspects and embodiments have been discussedabove, those of skill in the art will recognize certain modifications,permutations, additions and sub-combinations thereof. It is thereforeintended that the claims hereafter introduced may cover and should beinterpreted to include all such modifications, permutations, additionsand sub-combinations as are within their true spirit and scope.

1. An apparatus comprising: a cordless, hand-held ultrasound devicecomprising a display to display ultrasound images, touch sensitivecontrols configured to adjust settings of the hand-held ultrasounddevice, and a transducer comprising a transducer array, the transducerconfigured to transmit ultrasonic pulses into a subject and to receivereflected ultrasonic pulses which have been reflected at locationswithin the subject; and a sterile enclosure completely enclosing thehand-held ultrasound device such that any material on the hand-heldultrasound apparatus is prevented by the sterile enclosure fromcontaminating a sterile environment in which the hand-held ultrasounddevice is used while in the sterile enclosure, the enclosure comprising:an opening for insertion of the hand-held ultrasound device into theenclosure and removal of the hand-held ultrasound device from theenclosure; a closure for closing the opening; anacoustically-transparent transducer portion covering an active face ofthe transducer; and a transparent display portion overlaying the displayof the hand-held ultrasound device to permit viewing of the displaythrough the transparent display portion, the display portion sealed tothe transducer portion to maintain sterility; wherein: the transducerportion of the enclosure comprises a semi-rigid gel pad shaped toconform to the active face of the transducer; the gel pad comprises amaterial that holds its shape and is formed with projections and/orrecesses configured for engagement with corresponding recesses and/orprojections on the ultrasound device; the enclosure comprises flexibleportions overlaying the touch-sensitive controls; and the enclosure hasa shape that conforms to features of configuration of the hand-heldultrasound device.
 2. An apparatus according to claim 1, comprising aneedle guide attachable to the enclosure, the needle guide having a borefor receiving a needle, the bore aligned relative to a position of thetransducer in the enclosure so that the needle is projectable into afield of view of the transducer.
 3. An apparatus according to claim 1,wherein the enclosure comprises an integrally formed needle guide, theneedle guide having a bore for receiving a needle, the bore alignedrelative to a position of the transducer in the enclosure so that theneedle is projectable into a field of view of the transducer.
 4. Anapparatus according to claim 1 wherein the hand-held ultrasound devicecomprises a microphone and voice-recognition apparatus and is configuredto be controlled in response to voice or other sound commands receivedthrough the sterile enclosure.
 5. An apparatus according to claim 1wherein the sterile enclosure comprises elastic material stretched overthe display of the hand-held ultrasound device.